What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Immediate Lymphatic Reconstruction, Volumetric arm measurements, or Lymphatic massage. The registry lists allocation as na. The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.
They plan to enroll about 285 people at 7 sites. Taking part typically means a procedure as part of the study plus check-ins.
Official title (unrewritten)
A Prospective Cohort Study of Patients Undergoing ALND for Treatment of Breast Cancer: The Efficacy of a Comprehensive Prevention Program in Decreasing the Incidence of Lymphedema and Improving Quality of Life
Interventions: Immediate Lymphatic Reconstruction, Volumetric arm measurements, Lymphatic massage, Range of motion exercises, Compression garment use
Primary outcome (registry wording): The difference between the baseline and postoperative arm volume measurement